01 1TRUTAG TECHNOLOGIES, INC. Kapolei US
01 1Silica, colloidal anhydrous
01 1U.S.A
01 1Valid
Certificate Number : R0-CEP 2020-282 - Rev 00
Status : Valid
Issue Date : 2022-10-03
Type : Chemical
Substance Number : 434
25
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A Celite 512 medium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Celite 512 medium, including repackagers and relabelers. The FDA regulates Celite 512 medium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Celite 512 medium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Celite 512 medium supplier is an individual or a company that provides Celite 512 medium active pharmaceutical ingredient (API) or Celite 512 medium finished formulations upon request. The Celite 512 medium suppliers may include Celite 512 medium API manufacturers, exporters, distributors and traders.
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A Celite 512 medium CEP of the European Pharmacopoeia monograph is often referred to as a Celite 512 medium Certificate of Suitability (COS). The purpose of a Celite 512 medium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Celite 512 medium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Celite 512 medium to their clients by showing that a Celite 512 medium CEP has been issued for it. The manufacturer submits a Celite 512 medium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Celite 512 medium CEP holder for the record. Additionally, the data presented in the Celite 512 medium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Celite 512 medium DMF.
A Celite 512 medium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Celite 512 medium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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